Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of treanda™ (bendamustine hcl) in patients with indolent non-hodgkin's lymphoma (nhl) who are refractory to rituximab

Conditions: Non-Hodgkin's Lymphoma

Summary: summary: this is a multi-center open label study to evaluate the safety and effectiveness of treanda™ (also known as bendamustine hcl or sdx-105) in patients who have indolent non-hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (rituxan®). treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.


Eligibility criteria:
eligibility: key inclusion criteria * documented b-cell non-hodgkin's lymphoma * small lymphocytic lymphoma (alc \< 5,000 cells/mm3) * marginal zone b-cell lymphoma (nodal, extranodal, or splenic types) * lymphoplasmacytic lymphoma * follicular center lymphoma, follicular disease documented to be refractory to a full-course of the most recent rituximab therapy (single agent or combination) * at least 1 prior chemotherapy regimen and maximum of 3 prior chemotherapy regimens * bidimensionally measurable disease (by ct scan) with at least one lesion measuring ≥ 2.0 cm in a single dimension key exclusion criteria * patients who receive rituximab only as part of treatment with ibritumomab tiuxetan (zevalin®) will not be eligible * history of prior high dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible)

Keywords: lymphoma, non-hodgkin rituximab refractory rituximab failure indolent non-hodgkins lymphoma
evaluation of the dental vibe injection comfort system

Conditions: Anesthesia, Local; Pain

Summary: this study investigated the dental vibe injection comfort system (dv), developed to lessen anesthesia pain through pulsed vibration, a form of counter-stimulation. the study's aims were to evaluate dv's efficacy in reducing pain/discomfort from intra-oral long buccal (lb) and inferior alveolar nerve (ian) injections and the time needed to achieve complete anesthesia during an ian block.

objective: pain from local anesthesia injections can be reduced by distraction and counter-stimulation techniques. this study investigated the dental vibe injection comfort system (dv), developed to lessen anesthesia pain through pulsed vibration, a form of counter-stimulation. design: our study's aims were to evaluate dv's efficacy in reducing pain/discomfort from intra-oral long buccal (lb) and inferior alveolar nerve (ian) injections and the time needed to achieve complete anesthesia during an ian block. methods: the sixty subjects, equally split by sex, ages 21-32, rated injection pain on a visual analog scale and discomfort, unpleasantness, and difficulty in enduring the injection on a modified symptom severity index. each subject received bilateral lb injections and an ian block. using block design, dv generation 3 (dv3) was randomly assigned to either the first or second lb injection and to thirty subjects on their third injection, the ian block. no topical anesthesia was applied.

Eligibility criteria:
inclusion criteria: able to volunteer for dental anesthesia - exclusion criteria: non volunteer -

Keywords: anesthesia, local pain
trial to demonstrate the efficacy and safety of conversion to lacosamide monotherapy for partial-onset seizures

Conditions: Epilepsy

Summary: the objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to lacosamide monotherapy in subjects with partial-onset seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

sudden unexplained death in epilepsy have been reported in epilepsy patients. a causal relationship with the administration of antiepileptic drugs has not been established. the most important known risk factor for sudden unexplained death in epilepsy (sudep) is the occurrence and frequency of generalized tonic-clonic seizures (gtcs). twenty-seven patients with only gtcs were enrolled in the conversion to monotherapy study. in this study, two patients with only gtcs had sudep. due to the potential increased risk of sudep in patients with only gtcs in a trial setting, the 1 remaining patient with only gtcs was withdrawn from this study.

Eligibility criteria:
inclusion criteria: * subject has a diagnosis of epilepsy with simple partial seizures (motor component) and or complex partial seizures (with or without secondary generalization) * must be experiencing 2 to 40 seizures per 28-day period * stable dose of 1 or 2 marketed antiepileptic drugs * second antiepileptic drug (aed) must be less than or equal to 50 % of the minimum recommended maintenance dose per usa product label at screening exclusion criteria: * subject has a history of primary generalized or unclassified seizures * seizure disorder primarily characterized by isolated auras * history of status epilepticus * seizures that are uncountable due to clustering * has greater than 5 seizures/day * subjects taking benzodiazepines, phenobarbital or primidone * subject has vagus nerve stimulation (vns) * significant medical or psychiatric condition * history of alcohol or drug abuse * history of ethosuximide use, felbamate use after 1994 or vigabatrin use after 1997

Keywords: epilepsy partial onset seizures lacosamide monotherapy vimpat
high vs low volume intensity training with imt on pulmonary function and breathing efficiency on recreational swimmers.

Conditions: Healthy Young Adults

Summary: this study aims to evaluate the impact of inspiratory muscle training (imt) on respiratory function and swimming performance in competitive swimmers. given the importance of optimal respiratory function in swimming, this trial investigates whether imt can improve swimming performance metrics, such as lap times and endurance, and overall respiratory health.

effective respiratory function is crucial for swimmers, given the demanding nature of the sport. inspiratory muscle training (imt) has been shown to improve respiratory muscle strength and endurance in various populations. this study aims to explore the effects of imt specifically on competitive swimmers, assessing both physiological and performance-related outcomes. to assess whether a structured imt program improves swimming performance, respiratory muscle strength, and overall respiratory efficiency in recreational swimmers. a randomized controlled trial involving 56 competitive swimmers will be conducted. the study duration will be 8 weeks, with assessments conducted at baseline, mid-point, and at the end of the intervention. the imt groups will participate in a 20-30 minute training session, 4 to 5 times per week, using power breath device . the training will focus on enhancing inspiratory muscle strength and endurance. this study aims to provide robust evidence on the benefits of imt for swimmers, potentially informing future training practices and enhancing competitive performance.

Eligibility criteria:
inclusion criteria: * male and female swimmers * age; 18-25 * minimum of 2 years of regular swimming training experience, with at least 3 swimming sessions per week. exclusion criteria: * refusal to participate in the study. * history of respiratory or cardiovascular conditions that could impact participation or results. * participation in any other respiratory or exercise-related intervention study within the last 6 months. * consumption of any medications or supplements that could potentially influence respiratory or cardiovascular function.

Keywords: inspiratory muscle training high volume intensity training low volume intensity training swimmers
safety and efficacy of regn2477+regn1033 in patients with sporadic inclusion body myositis

Conditions: Sporadic Inclusion Body Myositis

Summary: the primary objective of the study is to evaluate the efficacy of regn2477+regn1033 in combination on total lean mass, as measured by dual-energy x-ray absorptiometry (dxa) in patients with sporadic inclusion body myositis (sibm). the secondary objectives of the study are: * to evaluate the efficacy of regn2477+regn1033 on the ibm-functional rating scale (ibm-frs) * to evaluate the efficacy of regn2477+regn1033 on the sibm physical functioning assessment (sifa) * to evaluate the safety and tolerability of regn2477+regn1033 * to evaluate the effects of regn2477+regn1033 on body composition by dxa, including appendicular lean mass and total fat mass * to evaluate the efficacy of regn2477+regn1033 on measures of muscle performance and physical function * to evaluate the efficacy of regn2477+regn1033 on patient reported outcome measures including the fear of falling, falls and near falls, and health-related quality of life * to evaluate the pharmacokinetic(s) (pk) profile of regn2477+regn1033, including functional regn2477 and functional regn1033 concentrations in serum over time * to evaluate the immunogenicity of regn2477+regn1033


Eligibility criteria:
key inclusion criteria: * men and postmenopausal\* women * diagnosed with sibm based on the european neuromuscular centre (enmc) ibm research diagnostic criteria * ability to walk ≥150 meters, with or without a walking aid such as cane or walker, in 6 minutes. * ability to climb 4 steps of stairs unassisted (may use handrails) * willing and able to comply with clinic visits and study-related procedures key exclusion criteria: * other neurological conditions (eg, hemiplegia post stroke, parkinson's) or musculo-skeletal conditions (eg, severe osteoarthritis) causing mobility impairment * mini-mental state examination (mmse) score \<24 * ongoing, chronic, high-dose (\>20 mg prednisone equivalent per day), systemic corticosteroid therapy within 6 weeks prior to screening. * any condition that precludes adequate intake of energy and protein; malnutrition; presence of an eating disorder. * unintentional weight loss of ≥10% in the past 6 months (patient-reported) * hospitalization for heart failure in last year or new york heart association class 4 * history of hypertrophic cardiomyopathy * any drugs known to influence muscle mass and performance such as anabolic steroids or growth hormone within 6 weeks prior to screening * unable to fit on the site's dxa scanner table, within borders for scanning of total lean mass note: other protocol inclusion/exclusion criteria apply
this was a multinational study comparing the efficacy and safety of two medicines , solifenacin succinate and mirabegron taken together, or separately, or a mock treatment (placebo) in subjects with symptoms of overactive bladder

Conditions: Urinary Bladder Overactive; Urinary Bladder Diseases\Urologic Diseases; Overactive Bladder; Urgency Incontinence

Summary: the purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.


Eligibility criteria:
inclusion criteria: * subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings; * subject had symptoms of "wet" oab (urinary frequency and urgency with incontinence) for at least 3 months; exclusion criteria: * subject had significant pvr volume (\> 150 ml); * subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and parkinson's disease with autonomic component or bladder involvement). an autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion. * subject had an indwelling catheter or practices intermittent self catheterization. * subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis. * subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin. * subject had moderate to severe hepatic impairment * subject had severe renal impairment * subject had a clinically significant abnormal ecg * subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening. * subject had an average qtcf interval \> 450 ms for males or \> 470 ms for females based on the triplicate ecgs completed at screening or is at risk of qt prolongation (e.g., family history of long qt syndrome, hypokalaemia). * subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmhg and/or average diastolic blood pressure ≥ 110 mmhg.

Keywords: combination therapy mirabegron overactive bladder urgency urinary incontinence nocturia solifenacin succinate
mechanisms of altered ventilatory control in heart failure

Conditions: Heart Failure

Summary: this study is being done because the investigators are trying to understand how feedback from the muscles can influence your blood pressure and breathing during exercise, and if the investigators can reduce this response in heart failure patients. the investigators are also trying to determine ways to improve tolerance to exercise in heart failure patients.

if you are enrolled in this study the investigators will ask you to make 3 separate study visits. during study visit 1 you will be asked to get a blood draw, dexa bone scan, perform pulmonary function tests, and exercise on a stationary bike at maximal exertion while breathing into a mouth piece. during study visits 2 and 3 you will be asked to again exercise at maximal exertion while breathing into a mouth piece. however, during these two visits you will be receiving an intrathecal injection of fentanyl one day and placebo the other day, randomly selected and you will be blinded as to which you are receiving. a catheter will also be placed in an artery in your arm and a vein in your leg, which will help us to measure blood flow, blood pressure and draw blood when need be. the investigators will also ask you to perform a brief chemosensitivity test, breathing in and out your own air, after you are done exercising.

Eligibility criteria:
inclusion criteria (heart failure patients): * history of ischemic or idiopathic dilated cardiomyopathy * new york heart association class 1-3 * no history of dangerous arrhythmia's * not pacemaker dependent * body mass index less than or equal to 35 kg/m * current non-smokers with less than 15 pack year history * non-pregnant women * individuals who are able to exercise without orthopedic limitations * all patients will be managed by their primary care physician or cardiologist prior to enrollment to ensure inclusion and exclusion criteria have been satisfied and participation in exercise testing is safe. control participants: * will be matched for age, gender, height and weight and will have no history of cardiovascular related abnormalities. * body mass index less than 35 kg/m * current non-smokers with less than 15 pack year history * non-pregnant women * individuals who are able to exercise without orthopedic limitations

Keywords: heart, cardiovascular pulmonary skeletal muscle exercise
american registry of ambulatory or acutely decompensated heart failure

Conditions: Heart Failure; Acute Heart Failure (AHF); Chronic Heart Failure

Summary: the purpose of this study is to better characterize and understand the population of patients with ambulatory or acutely decompensated heart failure in the american continent, getting to know their sociodemographic, clinical and paraclinical characteristics

an observational, prospective and multicenter study in which ambulatory patients with a confirmed diagnosis of heart failure and those admitted to the hospitalization service due to an episode of acutely decompensated heart failure will be invited to participate in order to better characterize this population participants who meet the eligibility criteria will be evaluated at the moment of recruitment. follow-ups will be performed at 1, 6 and 12 months after the initial registry for hospitalized patients. for ambulatory patients follow-up will only be performed at 12 months. these initial evaluations and subsequents follow-ups will be carried out using a standardized form for the collection of hospital and outpatient data through an electronic platform the purpose of this study is to know sociodemographic, clinical (clinical presentation, hemodynamic profiles, in-hospital and outpatient management, re-hospitalization rate, proportion of mortality, cumulative survival and heart failure readmission-free survival) and paraclinical characteristics of this population

Eligibility criteria:
inclusion criteria: * patient aged 18 years or older and one of the following: * hospitalized patient with admission diagnosis of acutely decompensated heart failure or * outpatient with confirmed diagnosis (main or complementary) of heart failure exclusion criteria: * hospitalized patient with principal diagnosis of another cardiovascular / non-cardiovascular pathology and who develops an acute decompensation of heart failure during hospitalization. * patient on heart transplant waiting list * patient who has implanted or is in process of implanting a long-term ventricular assist device (eg, heart mate ii, heart mate iii) as a target therapy or bridge therapy to other therapies * patient in whom palliative management has been previously defined for his/her cardiac condition (i.e. heart failure) or for another associated medical condition (cancer, chronic obstructive pulmonary disease (copd), etc.) * patient who is discharged or referred to another institution within 48 hours of hospital stay * inability to comply with programmed follow-ups (telephone or in person) due to social, personal or other conditions considered by the principal investigator * life expectancy less than 6 months given a condition other than heart failure (cancer, copd, etc.)

Keywords: decompensated outpatient treatment hospitalization mortality heart failure americas registry inpatient
effect of virtual reality immersion on patient's anxiety during pre-oxygenation before general anaesthesia

Conditions: Virtual Reality; Pre-oxygenation; Anxiety

Summary: the goal of this clinical trial is to learn if the use of virtual reality immersion during pre-oxygenation before general anesthesia could be feasible and beneficial for the patient. the main questions it aims to answer are: does virtual reality immersion during pre-oxygenation reduce patient's anxiety? does it impact patient's and anaesthetist's comfort? is this technique easy to implement?


Eligibility criteria:
inclusion criteria: * all non-ambulatory patients undergoing elective surgery or procedure under general anaesthesia with intravenous induction * minimal age of 18 year old * able to give informed consent for the study as documented by signature exclusion criteria: * lacking capacity or ability to complete the consent form and/or questionnaire and interview method and/or incapacity to respond to the required obligations linked to the study protocol (assessed by the operator) * known cognitive dysfunction, previous history of neurological/psychiatric disease like epilepsy * depression or anxiety under treatment * non-italian speaking patients * anticipated difficult airway management * injuries to the head/face that would prohibit wearing headsets * active nasal bleeding or occlusion, nasal abnormality or recent nasal trauma, recent nasal surgery, significant raised intracranial pressure and base of skull fractures * any pre-operative premedication, including pharmacological premedication * rapid sequence induction * haemodynamic instability * infectious skin conditions on the head/face * undrained pneumothorax * contact isolation due to bacteria and viruses * symptoms of vertigo or motion sickness * reduced visual or auditory acuity * bmi \> 35 kg/m2 * pregnancy * claustrophobia * pre-existing hypoxemia (baseline oxygen saturation \< 92% when breathing room air) * need for an arterial line before general anaesthesia induction
ultrasound assessment of gastric contents in fasted patient undergoing cholecystectomy

Conditions: Gastroparesis

Summary: investigators assess the gastric contents by ultrasonography in fasted patients undergoing cholecystectomy.

investigators evaluate the gastric volume through cross sectional area and amount of clear fluid using perlas grade by ultrasound in the supine and right lateral position of fasted patients undergoing cholecystectomy. full stomach is regarded if solid gastric contents are detected or clear fluid is more than 1.5 ml/kg. the frequency of full stomach will be analyzed.

Eligibility criteria:
inclusion criteria: * patients scheduled for cholecystectomy exclusion criteria: * presence of gastric anatomic abnormality or pathology * a previous surgery of esophagus or stomach * current pregnancy * who could not lie in the right lateral decubitus (rld) position
tfh dysfunction in hiv and aging

Conditions: Human Influenza

Summary: the purpose of this research is to evaluate blood samples from hiv infected and non-hiv infected people to understand how aging and hiv infection affect the immune responses (body defenses against infection) to the flu vaccine.


Eligibility criteria:
inclusion criteria: 1. for hiv positive participants: * hiv infection, as documented by any licensed elisa test kit. participants on art as a result of prior hiv documented infection will not be required to provide proof of diagnosis of hiv infection. * additional criteria for hiv positive 1. on art for at least 1 year. occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment, 2. cluster of differentiation 4 (cd4) count available in the prior 6 months and \>200/mm3 3. undetectable viral load (\< 40 copies/ml). blips of \<1000 copies/ml will be allowed. 2. for hiv negative participants: * documented negative hiv test at the time of study entry, either by any licensed elisa. 3. for all participants: 1. individuals age: ≤35 years and ≥65 years. 2. no history of other immunodeficiency disorders 3. not on steroid or other immunosuppressive/immunomodulators medications. 4. no active malignancies. 5. agreeable to receive both regular standard (std-tiv) and high dose (hd-tiv) influenza vaccination. 6. agreeable to participate in study for a complete course of study full visits including 2 consecutive flu seasons. 7. able to provide informed consent. exclusion criteria 1. contraindication to receive influenza vaccination. 2. non-adherence to art for hiv positive 3. unable to provide informed consent. 4. influenza vaccination already given during the current vaccination season. 5. known drug abuse including cocaine by history

Keywords: hiv aging flu vaccination high dose vaccination immune function